Stereotactic Ablative Radiotherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRaquibul Hannan, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed Graphics Processing Unit based computation treatment planning systems. We also plan to determine the safety of treatment to the prostate. Health-related quality of life will be measured as part of current clinical practice. * Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal using 90 day acute toxicity endpoint * Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal region at each treatment fraction by using cone-beam CT (CBCT) information and high speed GPU based computation treatment planning systems * Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate * Determine the feasibility and safety of temporal enhanced ultrasound for prostate lesion tracking during radiation therapy * To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS), distant metastasis (DM) free survival, and overall survival (OS) * Health-related quality of life (HRQOL) will be measured as part of current clinical practice Patients in each dose cohort will all be treated as a single group for dose escalation. There will be two levels of dose escalation-to prostate lesions and to pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences. The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive an additional 0.5Gy per treatment (total of 2.5Gy per escalation).

Eligibility Criteria

Men over 18 with high-risk prostate cancer (Gleason score ≥8, PSA ≥20 ng/ml, or advanced stage) who can undergo MRI and are eligible for a rectal spacer. They must agree to use contraception during treatment and be able to give informed consent. Excluded are those with prior pelvic cancer treatments, certain heart conditions, active infections, recent TURP surgery, planned antineoplastic therapies, metastases evidence after staging studies, severe co-morbidities like AIDS or significant psychiatric illness.

Inclusion Criteria

Signed study specific informed consent form

My PSA level is 20 ng/ml or higher, or I haven't started hormone therapy for prostate cancer yet.

My lymph nodes are not cancerous as confirmed by tests within the last 3 months.

+13 more

Exclusion Criteria

I have not had pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.

I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.

Patients should not have a history of significant psychiatric illness

+6 more

Participant Groups

The trial tests the highest safe radiation dose that can be given to the prostate and pelvis using Stereotactic Ablative Radiotherapy (SABR). It also assesses real-time planning safety with cone-beam CT scans and GPU systems for each treatment fraction. The study aims to determine if higher doses improve tumor control without compromising quality of life.

1Treatment groups

Experimental Treatment

Group I: Stereotactic Ablative RadiotherapyExperimental Treatment1 Intervention

Stereotactic Ablative Radiotherapy (SABR)

Stereotactic Ablative Radiotherapy (SABR) is already approved in European Union, United States, United Kingdom for the following indications:

🇪🇺 Approved in European Union as SABR/SBRT for: